Psoriasis
Conditions
Brief summary
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment with DSXS .
Detailed description
Evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe scalp psoriasis. Evaluate the efficacy parameters and adverse event (AE) profiles of DSXS topical product administered to patients with moderate to severe scalp psoriasis.
Interventions
once daily for 28 days
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or non-pregnant, non-lactating females 18 years of age or older. * IRE-approved, signed informed consent form that meets all criteria of current FDA regulations.
Exclusion criteria
* Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients in the Study With HPA Axis Suppression | 28 days | Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dsxs Topical Product treatment with DSXS once daily for 28 days
DSXS Topical product: once daily for 28 days | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Dsxs Topical Product |
|---|---|
| Age, Continuous | 48.8 years STANDARD_DEVIATION 17.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Percent Scalp Affected with Plaque Psoriasis | 42.2 percent of scalp STANDARD_DEVIATION 22.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 19 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 6 / 23 |
| serious Total, serious adverse events | 1 / 23 |
Outcome results
Primary
Proportion of Patients in the Study With HPA Axis Suppression
Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation
Time frame: 28 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dsxs Topical Product | Proportion of Patients in the Study With HPA Axis Suppression | Yes | 1 Participants |
| Dsxs Topical Product | Proportion of Patients in the Study With HPA Axis Suppression | No | 13 Participants |